| CTRI Number |
CTRI/2026/01/100414 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Great lock yoga practice on heart function and blood pressure changes in yoga practitioners. |
|
Scientific Title of Study
|
Effect of Maha bandha on autonomic functions among yoga practitioners: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harini RA E |
| Designation |
PG Scholar Department of Yoga |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai - 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9176938893 |
| Fax |
|
| Email |
drharinirae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Lakshmi |
| Designation |
Professor and Head, Department of Yoga |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai - 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9841073029 |
| Fax |
|
| Email |
lakshmikaran28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harini RA E |
| Designation |
PG Scholar Department of Yoga |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai - 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9176938893 |
| Fax |
|
| Email |
drharinirae@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and hospital, Arignar Anna Indian Medicine Campus, Arumbakkam, Chennai - 600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai, Tamil Nadu, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Harini RA E |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Yoga, Second floor, Government Yoga and Naturopathy Medical College and Hospital, PG Block, Arumbakkam, Chennai - 600106.
Chennai
TAMIL NADU |
9176938893
drharinirae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers aged between 18-35 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breath awareness practice |
Participants will be instructed to sit in easy pose with hands on the knees and will be guided to observe natural breathing pattern for 15 minutes per session, once a day for 5 days a week for 2 weeks. |
| Intervention |
Maha bandha practice |
Maha bandha which combines Jalandhara bandha, Uddiyana bandha and Moola bandha will be instructed to practice in 2 sets each consisting of 5 rounds for 10 minutes. Before and after each Maha bandha session, breathing awareness in between for 5 minutes will be instructed to practice. The total intervention time will be 15 minutes per session, once a day for 5 days a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy adults willing to participate in the study by signing the consent form.
|
|
| ExclusionCriteria |
| Details |
1.Participants with any co-morbidities like respiratory illness, hypertension, vertigo, cervical spondylitis, hernia, metabolic disorders, etc
2.Participants under any medication/treatment/ supplement
3.Participants involved in another research study
4.Female participants during the menstrual cycle, pregnancy, and lactation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability (HRV) |
Heart Rate Variability (HRV) will be taken before and two weeks after the first and last day of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure (BP) |
Blood Pressure (BP) will be taken before and two weeks after the first and last day of intervention |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. A randomized controlled study design will be adopted for this study. 50 participants will be recruited from Government Yoga and Naturopathy medical college and hospital, Chennai. Participants will be randomly allocated into study group (Maha bandha) or Control group (Breathing awareness) using computerized randomization technique, allocation concealment will be done using SNOSE (Sequentially Numbered Opaque Sealed Envelope) technique. The study group will undergo Maha bandha practice for 15 minutes, once a day, 5 days a week for 2 weeks. The control group will undergo breath awareness for 15 minutes, once a day, 5 days a week for 2 weeks. Assessment of Heart rate variability and blood pressure will be taken before and 2 weeks after the intervention for both group. |